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Silver Diamine Fluoride Pilot Study (SDF) (SDF)

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ClinicalTrials.gov Identifier: NCT02591147
Recruitment Status : Recruiting
First Posted : October 29, 2015
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Justine Kolker, University of Iowa

Study Description
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Brief Summary:
This pilot trial is randomized, double-blind, and placebo-controlled trial with two parallel arms: an intervention group using silver diamine fluoride (SDF) and a placebo group (control). 60 eligible healthy adults will be enrolled in the study and randomly assigned to one of the two treatment groups. Both groups will receive the traditional preventive measures including cleanings, Fluoride varnish, diet analysis and counseling. Study participants will be followed for one year and caries progression will be radiographically monitored.

Condition or disease Intervention/treatment Phase
Dental Caries Drug: Silver Diamine Fluoride 38% Drug: Group 2 (Placebo) Early Phase 1

Detailed Description:

This pilot study will compare 1) Silver diamine fluoride (SDF) and fluoride varnish to 2) Placebo and fluoride varnish (conventional prevention) in the management of early approximal carious lesions. Early approximal carious lesions refers to decay between teeth, diagnosed with radiographs, not extending more than 1/3 of the way into dentin. Management of early approximal carious lesions refers to halting lesion progression, or encouraging lesion reversal after an early carious lesion is detected.

SDF provides a novel, low-cost intervention option for managing early carious lesions that could potentially bridge the 'gap' between non-operative and operative options; thus, postponing the first placement of a restoration. SDF has been used in arresting carious lesions for more than 100 years. However, SDF has never been tested in the arrest of approximal caries lesions in permanent teeth.

SDF acts to both prevent and arrest tooth decay in multiple ways: 1) it acts on the body of carious lesions by precipitating silver ion into the lesion, thus blocking diffusion pathways for cariogenic acids; 2) it interacts with dental enamel leading to the formation of fluoroapatite crystals making the tooth surface more acid resistant; and 3) the precipitated silver from SDF acts as a bactericidal agent disturbing the formation of cariogenic biofilm.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Health Services Research
Official Title: Effectiveness of Silver Diamine Fluoride in Arresting Early Approximal Carious Lesion Progression: A Pilot Study
Study Start Date : October 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Silver Diamine Fluoride 38%
Group 1 (SDF 38%) will receive the application of silver diammine fluoride (38% SDF solution) in addition to 5% sodium fluoride varnish to each approximal carious lesion (scores RA1,RA2,RA3) in a posterior tooth (premolar or molar) that is in contact with an adjacent tooth, using super floss, for a duration of 3 minutes under rubber dam isolation.
 Drug: Silver Diamine Fluoride 38%
Group 1 (SDF group) subjects will receive the application of silver diamine fluoride (38% SDF solution) in addition to 5% Fluoride varnish to each approximal incipiency, using super floss, for a duration of 3 minutes under rubber dam isolation.
Other Name: 38% SDF
Placebo Comparator: Placebo (Sterile water)
Group 2 Placebo (control) will receive the application of sterile water (placebo) in addition to 5% sodium fluoride varnish to each approximal carious lesion (scores RA1,RA2,RA3) in a posterior tooth (premolar or molar) that is in contact with an adjacent tooth, using super floss, for a duration of 3 minutes under rubber dam isolation.
 Drug: Group 2 (Placebo)
Group 2 (Placebo) subjects will receive application of sterile water (placebo) in addition to 5% Fluoride varnish to each approximal incipiency, using super floss, for a duration of 3 minutes under rubber dam isolation.
Other Name: Sterile Water


Outcome Measures
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Primary Outcome Measures :
  1. Caries Progression [ Time Frame: 12 months ]
    comparison of radiographs to determine if there is caries progression in the subjects approximal lesions based on the radiographic examination.


Secondary Outcome Measures :
  1. Incidence of caries in all other teeth in the study subject [ Time Frame: 12 months ]
    Count for new carious lesions developing over the course of the study period to assess the effect of SDF on preventing the development of early carious lesions


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Presence of at least one approximal caries lesion (scores RA1, RA2, RA3 according to the ICCMS radiographic scoring system) in one of the posterior teeth (premolars and molars) presented with full contact with the adjacent tooth.
  • All the surfaces eligible for this study will be included.

Exclusion Criteria:

  • The approximal lesion detected in the radiograph has advanced dentine lesion (RB4, RC5, or RC6)
  • or is adjacent to a lesion that is either filled or will receive a filling at the time of enrollment.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02591147


Contacts
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Contact: Karen M Kluesner, RN 319-335-7377 karen-kluesner@uiowa.edu
Contact: Justine Kolker, DDS, MS 319-335-7583 justine-kolker@uiowa.edu

Locations
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United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Karen Kluesner, RN    319-335-7377    Karen-Kluesner@uiowa.edu   
Contact: Justine Kolker, DDS    319-335-7583    justine-kolker@uiowa.edu   
Sponsors and Collaborators
Justine Kolker
Investigators
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Principal Investigator: Michael Kanellis, DDS, MS University of Iowa
Principal Investigator: Justine Kolker, DDS, MS University of Iowa
More Information
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Publications:

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Responsible Party: Justine Kolker, Principal Investigator, University of Iowa
ClinicalTrials.gov Identifier: NCT02591147    
Other Study ID Numbers: 201509831
First Posted: October 29, 2015    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
 Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs